Total Shoulder Arthroplasty Multi-Center Registry



Status:Recruiting
Healthy:No
Age Range:18 - 100
Updated:5/16/2018
Start Date:July 28, 2015
End Date:November 10, 2027
Contact:Ginger Rappley, MS, CCRC
Email:ginger.rappley@arthrex.com
Phone:2395984302

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The objective of the study is a multi-center prospective registry to collect clinical
outcomes of anatomic and reverse total shoulder arthroplasty.

The study is a non-randomized multi-center prospective registry and subjects will be treated
according to standard of care at each center. Subjects will be approached for participation
in this study after they have made the decision to undergo a primary or revision shoulder
arthroplasty procedure. The treating surgeon will obtain verbal consent from the patient for
a research coordinator to screen for eligibility. Patients who meet all criteria will be
offered enrollment into the study. The total enrollment goal is a minimum of 500 anatomic
shoulder arthroplasty and 500 reverse shoulder arthroplasty subjects enrolled in the
multi-center registry.

Inclusion Criteria:

1. Patient voluntarily consents to participate in the study and has the mental and
physical ability to participate in the study, fill out subjective questionnaires,
return for follow-up visits, and comply with prescribed post-operative physical
therapy.

2. Patient is between the ages of 18 and 100 years.

3. An advanced pre-operative image (CT or MRI) has been acquired

4. Subject has failed 6 months of conservative treatment, unless acute humeral fracture,
and will be surgically treated with a primary or revision implantation of an anatomic
or reverse shoulder prosthesis system manufactured by Arthrex.

Exclusion Criteria:

1. Patient has known intentions, obligations, or co-morbidity that would inhibit them
from participating in the study

2. The patient has known co-morbidity that would make the subject ineligible for a
shoulder arthroplasty procedure

3. Patient declines participating in the study
We found this trial at
12
sites
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Cleveland, OH
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Chicago, IL
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from
Chillicothe, OH
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from
Columbia, MO
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from
Denver, CO
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from
Farmington, CT
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from
Grand Rapids, MI
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Greenville, South Carolina 29605
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Greenville, SC
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from
Lexington, KY
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from
Medford, OR
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from
Philadelphia, PA
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from
Phoenix, AZ
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